Family-based Childhood Behavior Intervention to Decrease Environmental Melamine and Phthalate Exposure

Not Applicable

Completed

• Conditions: Healthy Children and Their Main-care Giver
• Interventions: Behavioral: Assigned intervention; Behavioral: No intervention

• Registration Number: NCT02724722
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

Melamine and phthalates are environmental emerging chemicals, which are ubiquitously present in the public and easily contacted by children through air, foods, and skin. This study aims to examine whether the use of family-based behavior intervention by providing simple flyers plus face-to-face health education point-by-point and give one bag containing stainless steel-made tableware for eating out use to study children's mothers or main-care givers can significantly decrease melamine and phthalates exposure by measuring urinary melamine and metabolites of phthalates (especially DEHP metabolites) in study children and their mothers or main-care givers, when compared to those provided simple flyers only.

Detailed Description

Study subjects: Between May 31 and June 17, 2011, 108 children visited the special Phthalates Clinic for Children (PCC) at Kaohsiung Medical University Hospital (KMUH). Thirteen children whose age was older than 10 years, one girl with a history of hormone (leuprorelin) treatment, and thirty-four whose parents did not sign informed consents were excluded. The rest of 60 children are eligible to participate in this study. Because 37 out of the 60 potential study children did provide enough urine for the analyses of phthalates metabolites in our previous study \[Wu et al., 2013a; Wu et al., 2013b\], in this study, the investigators focus on the 37 study children. After the contact by phone, 24 study children and their mothers or main-care givers are willing to participate in this study intervention.

Study protocol: This is a family-based randomized intervention. The investigators will conduct this study for 2 weeks follow up. The investigators randomly assign 12 study children and their main-care givers (i.e., mothers or grandmothers) to a intervention group and another 12 to a control group. Intervention group means study children and their main-care givers (i.e., mothers or grandmothers) will receive face-to-face health education, besides provided the simple flyers and give one bag containing stainless steel-made tableware for eating out use, how to avoid environmental exposure to melamine and phthalate chemicals based on the evidence-based data from the investigators' laboratory and other researchers. The investigators only provide the simple flyers in a empty bag to the control group. The investigators will collect two one-spot urine samples from two consecutive mornings of the study children and their main-care givers, usually mother or grandmothers, at the baseline. Blood samples of the children were also collected measurement of endocrine profile, including TSH, T4, FT4, T3, and E2. After 2 weeks, another two one-spot urine samples from two consecutive mornings of the study investigators will collect two one-spot urine samples from two consecutive mornings of the study children and their main-care givers, usually mother or grandmothers, every 3 months for analyses.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2016-03-25
• Study First Posted: 2016-03-31
• Primary Completion: 2016-07
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 3-18-yrs healthy children and their main-care givers (i.e., mothers or grandmothers)

Exclusion Criteria

• Children with any hormone treatment or major chronic diseases such as cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Assigned intervention	a simple flyer in one empty bag with face-to-face health education
No Intervention	No intervention	a simple flyer in one empty bag with no face-to-face health education

Primary Outcome Measures

Name	Time	Method
urinary excretion of melamine	2 weeks
urinary excretion of five DEHP metabolites (MEHP, 5OH-MEHP, 5oxo-MEHP, 5carboxy-MEPP, and 2carboxy-MMHP)	2 weeks

Secondary Outcome Measures

Name	Time	Method
other six phthalate metabolites of MnBP, MiBP, MEP, MBzP, MMP, and MiNP	2 weeks
renal injury markers (NAG, microalbumin, beta-2-microglobulin)	one year
oxidative stress markers (8-OHdG, MDA)	one year

Trial Locations

Locations (1)

Kaohsiung Medical University; 🇨🇳 Kaohsiung, Taiwan